U.S. patent number 5,423,850 [Application Number 08/153,030] was granted by the patent office on 1995-06-13 for balloon compressor for internal fixation of bone fractures.
Invention is credited to J. Lee Berger.
United States Patent |
5,423,850 |
Berger |
June 13, 1995 |
Balloon compressor for internal fixation of bone fractures
Abstract
The present invention is directed toward a method for performing
an internal fixation of fractures of tubular bones using a balloon
catheter fixation device which is guided and transported through
the medullary canal and fracture site of the bone by a plurality of
guide wires mounted in said balloon catheter fixation device and
once placed in position in the bone inflated inside the bone and
tightened by applying pressure on the catheter outside of the bone
to apply a compression force across the fracture site enhancing the
stability of the fractured bone and promoting osseous healing.
Inventors: |
Berger; J. Lee (Franklin Lakes,
NJ) |
Family
ID: |
27506672 |
Appl.
No.: |
08/153,030 |
Filed: |
November 17, 1993 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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130434 |
Oct 1, 1993 |
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Current U.S.
Class: |
606/192;
604/96.01 |
Current CPC
Class: |
A61B
17/7225 (20130101); A61B 17/7275 (20130101); A61B
17/7266 (20130101); A61B 2017/00557 (20130101) |
Current International
Class: |
A61B
17/68 (20060101); A61B 17/72 (20060101); A61B
17/00 (20060101); A61B 017/18 () |
Field of
Search: |
;606/191,192,194,195,60-62 ;604/95-104,164 ;128/DIG.20 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pellegrino; Stephen C.
Assistant Examiner: Lewis; William W.
Attorney, Agent or Firm: Gipple & Hale
Parent Case Text
BACKGROUND OF THE INVENTION
1. Related Cases
This is a continuation-in-part of U.S. patent application Ser. No.
08/130,434, filed Oct. 1, 1993.
Claims
What is claimed:
1. A method of setting a fractured bone by compression comprising
the steps of:
a) cutting an aperture into one portion of the fractured bone away
from the site of the fracture allowing communication with the
medullary canal of the bone;
b) inserting a balloon catheter device and catheter guide wire
means through the aperture cut in the bone into the medullar cavity
of the bone;
c) transporting the balloon catheter in the medullary canal of the
bone past the fracture site by use of the catheter guide wire means
to a point distal from the fractured site;
d) inflating the balloon of the balloon catheter device to its
maximum diameter so that the balloon catheter device is held
securely in place by the positive pressure of the balloon applied
to the intramedullary walls of the bone; and
e) tensioning the attached catheter with the fixed balloon in place
by securing the catheter under tension to holding means to align
the fracture and compress the proximal and distal portions of the
fractured bone together.
2. The method of claim 1 including the step of; f) securing the
catheter firmly to the bone at the insertion site with a fastener
device.
3. The method of claim 2 wherein said securing step uses a screw as
the securing device.
4. The method of claim 2 wherein said securing step uses a bolt as
the securing device.
5. The method of claim 2 wherein said securing step uses a post as
the securing device.
6. The method of claim 1 wherein said cutting step uses an bone awe
to cut the aperture.
7. The method of claim 1 wherein said cutting step uses a bone
drill to cut the aperture.
8. An assembly for setting a fractured bone comprising a balloon
catheter with tubing, said balloon catheter defining an inflation
section which inflates when said balloon catheter is pressurized
and a plurality of throughgoing lumens, a guide wire mounted in
each of said lumens, said inflation section being inflated in a
fractured bone portion to fixedly engage said bone segment and
anchor means adapted mounted in another fractured bone portion
distal from said fractured bone portion, said anchor means being
secured to said catheter tubing to hold said balloon catheter in a
tensioned condition which provides compression on the fracture site
of fractured bone portions.
9. The assembly of claim 8 including a calibrated force measuring
device secured to said tubing to measure the compression force on
said balloon catheter.
10. The assembly of claim 8 including a pressure monitoring means
connected to said balloon catheter to measure the pressure of the
inflated balloon of said balloon catheter.
11. The assembly of claim 8 wherein said balloon catheter is a
plastic extruded material.
12. The assembly of claim 11 wherein said catheter tubing is
elastic and constructed of plastic.
13. The assembly of claim 8 wherein said holding means is a hollow
post with holding means.
14. The assembly of claim 8 wherein said balloon portion of said
balloon catheter has an outer wall which is ridged.
15. The assembly of claim 8 wherein said balloon portion of said
balloon catheter has an outer wall which is smooth.
16. The assembly of claim 8 wherein said balloon portion of said
balloon catheter has an outer wall which is fluted.
17. The assembly of claim 8 wherein said balloon catheter defines
two lumens.
18. The assembly of claim 8 wherein said balloon catheter defines
at a least three lumens.
19. The assembly of claim 8 wherein said guide wires are removably
mounted in said lumens.
20. The assembly of claim 8 wherein said guide wires are secured in
said lumens.
Description
2. Field of the Invention
The present invention is generally directed toward an apparatus for
the internal fixation of fractures of tubular bones by
compression.
3. Brief Description of the Background
Currently, fractured tubular bones are transfixed surgically by
either metal plates and screws or intramedullary metal rods.
It is known that with internal fixation of fractures with plate and
screw devices it is desirable to apply a compressive force across
the fracture site. Bone is a viscoelastic material and support of
structure and transmission of load is the mechanical function of
bone. Bone is strongest in compression and weakest in tension. When
a compressive force is applied across a fracture site it allows the
fractured segments of bone to be placed in close proximity and the
compressive force stimulates the bone in healing. If compression is
applied at the fracture site, the intimate contact of the bone
fragments restores the structural stability of the bone and allows
the direct transfer of force from fragment to fragment rather than
only through the implant. A compressive force applied directly at
the fracture site hastens the healing of bone by encouraging the
formation of new osteons which bridge the fracture line promoting a
primary type of bone healing.
Some bone fracture realignment procedures involve insertion of a
wire into the medullary canal which is then guided through the bone
segments often in conjunction with a partially inserted nail for
leverage. When the segments are aligned, the nail is fully inserted
and the wire is withdrawn.
Metal intramedullary devices, which function as internal splints,
have been used for many years to align fractures of tubular bones.
These devices may take the form nails, U.S. Pat. No. 5,034,013;
tubular members, U.S. Pat. No. 4,467,794; or a multiple pin device,
U.S. Pat. No. 4,457,301. A steerable intramedullary fracture
reduction device having an elongated shaft with a steerable tip
pivotally mounted to the distal end of the shaft is shown by U.S.
Pat. No. 5,002,543. In this patent a tip actuating apparatus near
the proximal end of the shaft enables the operator to steer the tip
and the shaft into successive segments of the fractured bone, even
when the segments are transversely or rotationally displaced so
that the segment can be aligned by the shaft. Metal compression
devices which are used for fractures are shown by U.S. Pat. Nos.
4,275,717; 4,227,518; 3,779,239 and 3,760,802. The aforenoted metal
compression devices are generally directed towards a threaded rod
which is inserted within the medullary canal of a fractured tubular
bone. The rod is provided with a distal end having an expandable
spreadable sheath or fingers which expand upon rotation of the rod.
The proximal end of the rod is located outside of the bone and is
provided with a nut which holds the rod in place inside the bone
thereby causing the fractured bone portions to be held together.
U.S. Pat. No. 4,946,459 shows an intramedullary device for fixing
and extending separated portions of a long bone within the body of
a patient. The device has a tubular sleeve which is nailed to one
end of the bone and an adjustment assembly with a moveable member
which bears against an end of the nail. The moveable member can be
moved from outside the patient to adjust the separation between the
portions of the fractured bone.
The aforementioned prior art devices have metal fingers or sleeves
which engage the walls of the medullary canal of the bone with
deleterious effects.
The use of such prior art intramedullary devices involves the
reaming of the medullary cavity which has the effect of destroying
the inner lining of blood vessels. Furthermore the ends of long
bones in children are also the growth center of the bones. Drilling
or gouging through the ends causes damage and may stop or deform
further growth.
Other prior art devices currently use dynamic compression plates
and screw devices to apply compression across the fracture site.
However, for insertion of this type of device, it is necessary to
make a large surgical incision over the outer cortex of the bone
directly at the fracture site. Placing this type of fixation device
entails the disturbance of the soft tissues overlying the fracture
site, disturbance of the fracture hematoma, and stripping the
periosteium of bone which compromises the blood supply to the bone
at the fracture site.
A flexible bladder device has been described by U.S. Pat. No.
4,313,434 to align fractures intramedullarly. However, this bladder
device is designed to be placed directly at the fracture site to
provide fixation. The bladder device was not designed for
compression at the fracture site and when inflated at the fracture
site actually promotes separation of the fracture fragments and has
the opposite effect of the present balloon catheter compression
device.
There is no known intramedullary device currently available that
applies a compressive force at the fracture site in addition to
aligning the fracture.
SUMMARY OF THE INVENTION
An improved method and apparatus for treatment of fractures of
tubular bones relies on the principle of compressive force to align
fractures of tubular bones and to promote and hasten the healing of
such fractures. The intramedullary balloon of the balloon catheter
is designed to be guided and transported through the medullary
canal of the bone and placed either proximal or distal to the
fracture site. The balloon when inflated with sterile saline
solution is held securely in place in the medullary canal of the
bone acting as an intramedullary anchor for the balloon catheter.
It is the elastic property of the catheter that when tightened
against the rigid immobile force of the anchoring balloon allows
the fractured segments of the bone to align and come in intimate
contact. With further tightening of the catheter a compressive
force is applied across the fracture site.
It is an object of the invention to provide a fracture compression
device which minimizes damage to the interior blood vessels and
periosteium of the bone and allows the guide wire to be
removed.
In the accompanying drawings, there is shown an illustrative
embodiment of the invention from which these and other objectives,
novel features and advantages will be readily apparent.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross sectional schematic of the invention showing
insertion of the inventive balloon catheter device into the
bone;
FIG. 2 is a cross sectional schematic of the invention showing
fixation of the balloon catheter in the medullary canal of the bone
and compressive tightening of the fractured portions of the bone
with the sensing and fluid transmission elements shown in block
diagram; and
FIG. 3 is a cross section of the inflated balloon with a fluted
outer wall.
DETAILED DESCRIPTION OF THE INVENTION
A preferred embodiment and best mode of the invention is shown in
FIGS. 1 and 2. The intramedullary balloon compression device 10 is
used to treat fractures of tubular bones by applying intramedullary
compression at the fracture site.
When a tubular bone 40 is fractured at a fracture site 41 the
catheter device 10 can be inserted into the medullary canal 42 of
the bone through a small incision either proximal or distal to the
site of the fracture via a catheter introducer. A small aperture 44
is made in the outer cortex of the bone portion 46 with an
introducing bone drill and drill bit or bone awl to access the
medullary canal of the bone. Once the aperture 44 is created in the
bone, the balloon catheter device 10 with lead wire 12 and double
guide wires 13 and 15 or additional guide wires if such are needed
is inserted into the medullar cavity of the bone by a catheter
introducer 60. The balloon compression device 10 is preferably
constructed of a plastic extruded material such as polyethylene,
teflon, kevlar or other durable material is then guided by the
guide wires 13 and 15 past the fracture site 41 into the other
portion 48 of the fractured bone. The balloon catheter device 10 is
formed with a plurality of lumens 11 along its length for guide
wire insertion. Location of the lumens 11 are shown in phantom in
FIG. 2. The guide wires may be removable from the balloon catheter
or permanently incorporated in the catheter. The balloon 16 of the
catheter device is inflated to its maximum diameter via the elastic
catheter tube 14 with sterile saline solution by means of a syringe
18, associated feed tube 20 and a balloon pressure gauge monitor 22
as shown by respective block diagrams. It is envisioned that the
shape of the balloon 16 can be modified in various forms, including
smooth, fluted as shown in FIG. 3 or ridged outer walls for
promoting endosteal blood supply at the site of the balloon
insertion. The inflated balloon 16 is held securely in place by the
positive pressure applied to the intramedullary walls of the bone.
Once the balloon 16 is anchored in place past the fracture site 41,
the attached catheter tube 14 can be tightened. The catheter
tensioning device is provided with a calibrated force measuring
device such as a strain gauge 50 to measure the compression force.
The tightening of the catheter 14 with the fixed balloon 16 in
place aligns the fracture and compresses the proximal and distal
portions 46 and 48 of the fractured bone together. After alignment
and compression of the fracture with the intramedullary balloon
compression catheter, the catheter 14 is secured firmly to the bone
46 at it's insertion site 44 with a screw, post or peg type of
fixation device 30. Thus, the balloon compression catheter can be
incorporated into existing bone fixation technology such as an
intramedullary rod, a fixation screw or plate, hip screw or total
joint arthroplasty that uses a balloon catheter to enhance fixation
to the bone. If desired the post 30 can be hollow and exteriorly
threaded with the catheter tube 14 extending through the lumen 31
of the post 30 where the catheter tube 14 can be tied, clamped or
affixed to a cross post mounted to the bone fixation post or strain
gauge 50. The fixation post 30 and catheter 14 can be tightened, if
necessary, to apply further compression at the fracture site. After
the fracture heals, the balloon can be deflated and the balloon
catheter and fixation post can be easily removed from the bone. If
necessary, additional balloon catheters can be similarly positioned
in place for fixation. The balloon compression catheter can be used
independently for the intramedullary compression fixation of
tubular bones or can be used as a supplement to metal
intramedullary devices to apply compression across the fracture
site.
The balloon catheter compression device 10 is inserted through a
very small incision in the bone far away from the fracture site
with a catheter introducer. The balloon 16 itself is transported
through the medullary canal by the guide wires and is inflated away
from the fracture site and in doing so does not compromise the
extramedullary periosteal blood supply or the intramedullary blood
supply at the fracture site. The device does not disturb the
fracture hematoma which is essential for healing of the fracture.
The compression force of the catheter allows the fractured
fragments of bone to be aligned in close apposition promoting
healing of the fracture similar to the prior art dynamic
compression plate device without making an incision at the fracture
site and without compromising the blood supply at the fracture
site.
The intramedullary balloon compression catheter is designed
specifically to apply a compressive force at the fracture site, to
align the fractured bone and promote healing of the fracture.
Osteogenesis is promoted by compression across a fracture site and
the intramedullary balloon compression catheter facilitates this in
an intramedullary fashion.
In the foregoing description, the invention has been described with
reference to a particular preferred embodiment, although it is to
be understood that specific details shown are merely illustrative,
and the invention may be carried out in other ways without
departing from the true spirit and scope of the following
claims:
* * * * *